FDA.reportPublic FDA data

VITA ENAMIC STAIN white

Primary DI
E239M7001211
Brand
VITA ENAMIC STAIN white
Company
Innovation MediTech GmbH
Model
1
Catalog number
M700121
Device description
Colour powder for shade customization and characterization of the surface of dental restorations. 2 g bottle.
Published
2016-10-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBDCoating, Filling Material, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123761000VITA ENAMIC STAINSInnovation Meditech GmbH2013-03-01EBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E239M7001211PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313785693
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D239206411egger A/ITE vario20641206412025-08-29
E2392064111egger A/ITE vario2064112064112025-08-29
E239M700101VITA ENAMIC GLAZE1M700102016-10-18
E239M700111VITA ENAMIC STAINS LIQUID1M700112016-10-18
E239M7001221VITA ENAMIC STAIN corn1M7001222016-10-18
E239M7001231VITA ENAMIC STAIN brown1M7001232016-10-18
E239M7001241VITA ENAMIC STAIN blue1M7001242016-10-18
E239M7001251VITA ENAMIC STAIN black1M7001252016-10-18
E239M7001261VITA ENAMIC STAIN khaki1M7001262016-10-18
E239M1113001 Sonopal® hard Lacquer AlM111300M1113002020-09-21
E239M1113031Sonopal® hard Lacquer Al M111303M1113032020-09-21
E239M1113041Sonopal® hard Lacquer AlM111304M1113042020-09-21
E239M1113091Sonopal® hard Lacquer AlM111309M1113092020-09-21
E239M1115041Sonopal® soft Lacquer EM111504M1115042020-09-21
E239M1115051Sonopal® soft Lacquer EM111505M1115052020-09-21
E239M1115071Sonopal® soft Lacquer EM111507M1115072020-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E2395021000G1Grafitti® Colorgloss® Cure GlazeDreve Dentamid GmbHEBD2026-10-29
E235Y00030SHOFU RESIN GLAZESHOFU DENTAL CORPORATIONEBD2026-06-08
08809896990288ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991056ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991063ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
00810184450030RodinPac-Dent, Inc.EBD2026-05-15
08809896990172ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990189ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990196ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990202ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990219ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990226ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990233ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990240ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990257ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990264ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990271ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990295ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990387ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990400ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990417ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990424ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990431ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990448ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990455ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990462ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990479ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990486ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990493ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990509ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14